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Last Updated: April 13, 2024

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QSYMIA Drug Patent Profile


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When do Qsymia patents expire, and what generic alternatives are available?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch® Generic Entry Outlook for Qsymia

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 24, 2025. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for QSYMIA
Drug Prices for QSYMIA

See drug prices for QSYMIA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QSYMIA
Generic Entry Date for QSYMIA*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION
NDA:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for QSYMIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novo Nordisk A/SPhase 4
VIVUS LLCPhase 4
Alvogen KoreaPhase 4

See all QSYMIA clinical trials

Paragraph IV (Patent) Challenges for QSYMIA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
QSYMIA Extended-release Capsules phentermine hydrochloride; topiramate 3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg 022580 1 2013-07-18

US Patents and Regulatory Information for QSYMIA

QSYMIA is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QSYMIA is ⤷  Try a Trial.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QSYMIA

Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY

Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)

Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Low dose topiramate/phentermine composition and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Escalating dosing regimen for effecting weight loss and treating obesity
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)

FDA Regulatory Exclusivity protecting QSYMIA

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for QSYMIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 ⤷  Try a Trial ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 ⤷  Try a Trial ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 ⤷  Try a Trial ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 ⤷  Try a Trial ⤷  Try a Trial
Vivus QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for QSYMIA

When does loss-of-exclusivity occur for QSYMIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09257572
Estimated Expiration: ⤷  Try a Trial

Patent: 09257573
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0914985
Estimated Expiration: ⤷  Try a Trial

Patent: 0914991
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 27313
Estimated Expiration: ⤷  Try a Trial

Patent: 27319
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 10001365
Estimated Expiration: ⤷  Try a Trial

Patent: 10001366
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2112126
Estimated Expiration: ⤷  Try a Trial

Patent: 2112127
Estimated Expiration: ⤷  Try a Trial

Patent: 4825477
Estimated Expiration: ⤷  Try a Trial

Patent: 5534921
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18103
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 17997
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 00002
Estimated Expiration: ⤷  Try a Trial

Patent: 17997
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 13489
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9874
Estimated Expiration: ⤷  Try a Trial

Patent: 9875
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 52595
Estimated Expiration: ⤷  Try a Trial

Patent: 77053
Estimated Expiration: ⤷  Try a Trial

Patent: 14750
Estimated Expiration: ⤷  Try a Trial

Patent: 11522896
Estimated Expiration: ⤷  Try a Trial

Patent: 11522897
Estimated Expiration: ⤷  Try a Trial

Patent: 15166380
Estimated Expiration: ⤷  Try a Trial

Patent: 16006085
Estimated Expiration: ⤷  Try a Trial

Patent: 17078083
Estimated Expiration: ⤷  Try a Trial

Patent: 17105788
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 2684
Estimated Expiration: ⤷  Try a Trial

Patent: 10013503
Estimated Expiration: ⤷  Try a Trial

Patent: 10013505
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 17997
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1008839
Estimated Expiration: ⤷  Try a Trial

Patent: 1008840
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 110042280
Estimated Expiration: ⤷  Try a Trial

Patent: 110044847
Estimated Expiration: ⤷  Try a Trial

Patent: 140121491
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 06041
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QSYMIA around the world.

Country Patent Number Title Estimated Expiration
Mexico 2010013503 COMPOSICION DE TOPIRAMATO/FENTERMINA DE BAJA DOSIS Y METODOS DE USO DE LA MISMA. (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF.) ⤷  Try a Trial
South Africa 201008840 ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009152190 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008153632 ⤷  Try a Trial
Denmark 1187603 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QSYMIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2317997 CR 2021 00049 Denmark ⤷  Try a Trial PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
2317997 2190050-1 Sweden ⤷  Try a Trial PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
2317997 CA 2021 00049 Denmark ⤷  Try a Trial PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.